FDA considers trading faster drug reviews for lower prices
The idea could help the administration achieve one of President Donald Trump’s main health-care goals: ensuring foreign countries aren’t getting a better deal on drugs.
FDA
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FDA rejects Lilly drug for eczema due to inspection issues at outside manufacturer
Eli Lilly and Co. just hit another bump in the road in its quest to push deeper into treatments for skin diseases, the third setback this year for the Indianapolis-based drugmaker from the U.S Food and Drug Administration.
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Fishers biotech firm lands additional FDA approval for imaging product
Illuccix was first approved by the FDA in December 2021. The imaging agent is designed to target and “light up” cancerous cells, making it easier for oncologists to determine through a PET scan if the cells have spread to areas outside the prostate.
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FDA approves Lilly diabetes drug that helps patients lose weight
The drug has been closely watched by medical professionals and is viewed by financial analysts as a possible blockbuster, with potential annual sales in the billions of dollars.
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Lilly says experimental drug helped patients lose up to 22% of body weight
The drug, called tirzepatide, has been closely watched by medical professionals and is viewed by financial analysts as possible blockbuster, with potential annual sales in the billions of dollars.
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FDA begins sharing rejection letters drugmakers often kept secret
Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.
Nestle says it will remove artificial dyes from US foods by 2026
Nestle joins Kraft Heinz and General Mills as major food companies to pledge they would remove artificial dyes from their U.S. products.
FDA to offer faster drug reviews to companies promoting ‘national priorities’
Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months.
FDA to limit COVID vaccine approval to older adults, those with medical conditions
FDA leaders estimate more than 100 million Americans would still be eligible for the shots under the new framework.
FDA to phase out 8 artificial dyes from food supply
It would be a sweeping change for U.S. food producers, who would likely replace the dyes with natural substitutes.
FDA upheaval worries local companies
The Trump administration’s recent announcement that it plans to eliminate about 3,500 FDA jobs is creating uncertainty among Indianapolis-area companies that interact with the federal agency.
FDA reverses course on telework after layoffs, resignations threaten basic operations
Weeks after ordering all Food and Drug Administration employees back into the office, the agency is allowing some of its most prized staffers to work remotely.
Department of Health and Human Services to lay off 10,000 workers in major restructuring
The plan means cuts at the Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, and the Centers for Medicare and Medicaid Services.
Ultraprocessed foods come under fire. Here’s why.
Ultraprocessed foods have been linked to a host of negative health effects, from obesity and diabetes to heart disease, depression, dementia and more. And they make up most of the U.S. diet.
FDA bans red dye No. 3 from foods
Food manufacturers will have until January 2027 to remove the dye from their products, while makers of ingested drugs have until January 2028 to do the same.
Controversial red dye used in candy, drinks and snacks could soon be banned
The Food and Drug Administration is on the cusp of deciding whether to ban a controversial bright cherry-red dye that has been linked to cancer in animals.
FDA proposes new testing rules to ensure cosmetics are asbestos-free
The proposal from the Food and Drug Administration and mandated by Congress is intended to reassure consumers about the safety of makeup, baby powder and other personal care products.
FDA set to phase out leading decongestant in many cold medicines
Phenylephrine is used in popular versions of Sudafed, Dayquil and other medications, but experts have long questioned its effectiveness.
Lilly’s U.S. weight-loss drug shortage ends, curtailing copycats
The FDA had previously said Lilly’s drugs were out of shortage and that making copies must cease in October. Compounders sued, causing the FDA to pause enforcement while it reevaluated its decision.
Trump efficiency guru Ramaswamy could benefit from crusade against FDA
Vivek Ramaswamy owns about $670 million in shares of Roivant Sciences, which is pursuing studies for three drugs that could land before the FDA during Donald Trump’s second term.
Amid backlash, FDA changes course over shortage of Lilly weight-loss drugs
The U.S. Food and Drug Administration said it would not take enforcement action—for now—against pharmacies making their own versions of weight-loss drugs based on Eli Lilly’s tirzepatide.
Bakery that makes Sarah Lee, Entenmann’s pushes back on FDA sesame warning
Bimbo Bakeries USA appears to be defying an FDA warning sent in June that said the several of the company’s products are “misbranded” because the labels list sesame or tree nuts even though those ingredients aren’t in the foods.
Lilly seeks court ruling that could mean big money for new weight-loss drug
The Indianapolis-based drugmaker filed a suit in federal court this month, challenging the U.S. Food and Drug Administration’s ruling that the company’s experimental obesity treatment not a biological product.
Teen vaping hits 10-year low in United States
FDA officials noted that the drop in vaping didn’t coincide with a rise in other tobacco industry products, such as nicotine pouches, which have surged in use among adults.